MAH Transfer Date definition
Examples of MAH Transfer Date in a sentence
Until the MAH Transfer Date, the Regulatory Taskforce shall oversee and attend to the MAH Transfer from JT to GSJ, with a goal to achieve the MAH Transfer as quickly as practicable.
JT shall have the right to file and own Marketing Authorization Applications and Regulatory Approval for Products in Japan until MAH Transfer Date to the extent contemplated by the Master Agreement or Ancillary Agreements.
JT and Gilead will enter into an Amended and Restated Pharmacovigilance Termination Agreement (“Amended and Restated Pharmacovigilance Agreement Termination Agreement”) to be effective as of the MAH Transfer Date or any other date to be specifically agreed in the Amended and Restated Pharmacovigilance Agreement Termination Agreement.
In advance of the Marketer Change Date, JT and GSJ will enter into a Safety Information Reporting Agreement and Quality Information Reporting Agreement, both of which will be effective during the period from the Marketer Change Date to the MAH Transfer Date.
In furtherance thereof, JT hereby appoints GSJ as a promoter of such HIV Products as of the Marketer Change Date and until the MAH Transfer Date.
Subject to the Master Agreement and Transition Services Agreement, JT shall be responsible for making the filings for Regulatory Approval in Japan until the MAH Transfer Date.
Until the MAH Transfer Date, the Regulatory Taskforce shall oversee the sNDA.
Gilead will be responsible for processing all returns of any HIV Products sold by JT or its Affiliates on or after the MAH Transfer Date.
JT and its Affiliates has and will have through the MAH Transfer Date necessary procedures in place to prevent bribery and corrupt conduct by the JT Representatives under this Agreement and the Ancillary Agreements.
To the extent required by applicable regulatory requirements, Gilead shall file all Promotional Materials as required by the appropriate Regulatory Authority in the Gilead Expanded Territory; provided, however, that JT shall retain the rights to file the same in Japan until MAH Transfer Date to the extent contemplated by the Master Agreement or Ancillary Agreements.